3 Month PGDCR Course :

• Course Curriculum :This Clinical Research course is blending of E-Learning through series of lectures.


• Weekly lectures session by Experienced faculty


• Guest lectures of Clinical Research Industry professionals


• Practical lecture series from Research Investigators and Ethics Committee Members


• Case study learning

Why to choose Bhaktivedanta Hospital and Research Institute for online Course : Apart from online teaching , candidates would also be offered one , on –site hands on training. 

• Course Evaluation- There would be separate exam for every module . Candidate need to score atleast 70 % to be eligible for the next module . There would be additional Final exam which will be based on all the modules. 

• Module I – Basic of  Clinical Research and stakeholders in Clinical Research


• Module II – Ethics in Clinical Research and Ethical Guidelines


• Module III – Regulations in Clinical Research (Indian and Global)


• Module IV – Clinical Trial Monitoring, Audits and Inspections


• Module V– Clinical Data Management


• Module VI – Drug Safety and Pharmacovigilance 

• Eligibility for the Course

Minimum eligibility criteria for application to the course would be either of the following:

• Graduates in Life sciences/ Bio Sciences-(Biochemistry, Microbiology, Genetics, Biotech, Biology etc.)


• Physiotherapy, Occupational Therapy, Nursing Graduates


• Pharmacy Graduates


• Medical Graduate- MBBS, BAMS, BDS,BHMS


• Duration of course- 3 months, Saturday/Sunday Classes ( 3hrs Per Lecture )


• Limited Batch Size- 10 students only 

6 Month PGDCR Course :

• Course Curriculum :

This Clinical Research course in blending of E-Learning through series of lectures.

• Weekly lectures session by Experienced faculty


• Guest lectures of Clinical Research Industry professionals


• Practical lecture series from Research Investigators and Ethics Committee Members


• Case study learning

Why to choose Bhaktivedanta Hospital and Research Institute for online Course : Apart from online teaching , candidates would also be offered one , on –site hands on training .

• Course Evaluation- There would be separate exam for every module . Candidate need to score atleast 70 % to be eligible for the next module . There would be additional Final exam which will be based on all the modules .


• Module I – Basic of  Clinical Research and stakeholders in Clinical Research


• Module II – Basic Pharmacology in Clinical Research and New Drug Development


• Module III – Ethics in Clinical Research and Ethical Guidelines


• Module IV – Regulations in Clinical Research (Indian and Global)


• Module V – Clinical Research Methodology


• Module VI – Clinical Trial Monitoring, Audits and Inspections


• Module VII– Clinical Data Management


• Module VIII – Drug Safety and Pharmacovigilance


• Module IX – Soft Skills Training


• Module X – How to appear for Interviews 

• Eligibility for the Course

Minimum eligibility criteria for application to the course would be either of the following:

• Graduates in Life sciences/ Bio Sciences-(Biochemistry, Microbiology, Genetics, Biotech, Biology etc.)


• Physiotherapy, Occupational Therapy, Nursing Graduates


• Pharmacy Graduates


• Medical Graduate- MBBS, BAMS, BDS,BHMS


• Duration of course- 6 months, Saturday/Sunday Classes ( 3hrs Per Lecture )


• Limited Batch Size- 10 students only 

3 Months Course Hands On Training Experience : 

Features : Candidate will get to conduct one Clinical Trial ( One Research Project ). 

Internship- What a wonderful concept . As Bhaktivedanta Hospital has all required resources to provide internship , namely , patients , Research Medications , National & International Clinical Trials , hospital facility to conduct these clinical Trials , Specialist Doctors who are Investigators and can undertake any complex clinical trial , dedicated Research Associates , state of the art facility to undertake any clinical trial , govt accredited Research Committees , NABH Assessors at site .Each Student will be assigned few Clinical research projects since beginning of course itself.  Student will be provided ‘Internship certificate’ at the end of course which distinguish him/her during Job application process.

Hands on Training : We don’t believe in only theory classes or internship at the end of theory classes.  Both must happen parallel so as to understand the subject matter thoroughly ,  and hence we are offering hands on training simultaneously .  During course student will be exposed to ‘live –Clinical Research Operation’ process. It will help student to correlate class room learning to practical Clinical Research operations. Student will get opportunity to have following hands on trainings : …

1. Opportunity to work with centralized Medical Research Department .  Clinical Trials of all specialties , all clinical trials phases , various indications are happening in centralized Medical Research Department .


2. Opportunity to directly conduct International Clinical Trials .


3. Opportunity to receive direct training from Sponsors, Contract Research Organization, Medical Monitors and Principal Investigators.


4. Opportunity to learn communication skills to deal with external vendors required for Clinical Trials ( Monitors , Clinical Research Associate , Interactive voice response system Representatives , Interactive Web Response  representatives , Drug Controller General of India Office personnel , NABH Personnel , Ethics Committee Personnel)


5. Opportunity to directly report Clinical Trial Safety Information to Head of Institute , DCGI and Sponsors 


6. Opportunity to participate in Site Qualification Visit, Site Selection Visit , Site Initiation Visit , Site Monitoring Visit , Site Assessment Visit, Site Audit Visit , Site Close Out Visit.


7. Opportunity to understand functioning of  Institutional Ethics Committee, Committee for Biomedical Research , Committee for Investigator Initiative Study Research , Scientific Committee. 


8. Opportunity to directly network with CRO Sponsor so that it is easy to get good placements.


9. Clinical Trial Start up activities including Informed Consent Process


10. Data Management- electronic data entry software

Placement Assistance : We will groom our students to face industry. We will work with them to make future successful Clinical Research Professionals.

•  Training -Soft Skills for a Clinical Research Professional


•  Training-Resume customization and Job interview preparation


•  Personal Assistance for Job Placement of student across Hospitals, Pharmaceutical companies, Contract Research Organizations (CRO), Site Management Organizations (SMO), Research Hospitals

6 Months Course Hands On Training Experience :

Features : Candidate will get to conduct one Clinical Trial and one Investigator Initiated study

( Two Research Projects ) , Authorship in Publication if study completed in the said duration. 

Internship- What a wonderful concept . As Bhaktivedanta Hospital has all required resources to provide internship , namely , patients , Research Medications , National & International Clinical Trials , hospital facility to conduct these clinical Trials , Specialist Doctors who are Investigators and can undertake any complex clinical trial , dedicated Research Associates , state of the art facility to undertake any clinical trial , govt accredited Research Committees , NABH Assessors at site .Each Student will be assigned few Clinical research projects since beginning of course itself.  Student will be provided ‘Internship certificate’ at the end of course which distinguish him/her during Job application process.

Hands on Training : We don’t believe in only theory classes or internship at the end of theory classes.  Both must happen parallel so as to understand the subject matter thoroughly ,  and hence we are offering hands on training simultaneously .  During course student will be exposed to ‘live –Clinical Research Operation’ process. It will help student to correlate class room learning to practical Clinical Research operations. Student will get opportunity to have following hands on trainings : …

1. Opportunity to work with centralized Medical Research Department .  Clinical Trials of all specialties , all clinical trials phases , various indications are happening in centralized Medical Research Department .


2. Opportunity to directly conduct International Clinical Trials .


3. Opportunity to receive direct training from Sponsors, Contract Research Organization, Medical Monitors and Principal Investigators.


4. Opportunity to learn communication skills to deal with external vendors required for Clinical Trials ( Monitors , Clinical Research Associate , Interactive voice response system Representatives , Interactive Web Response  representatives , Drug Controller General of India Office personnel , NABH Personnel , Ethics Committee Personnel)


5. Opportunity to directly report Clinical Trial Safety Information to Head of Institute , DCGI and Sponsors 


6. Opportunity to participate in Site Qualification Visit, Site Selection Visit , Site Initiation Visit , Site Monitoring Visit , Site Assessment Visit, Site Audit Visit , Site Close Out Visit.


7. Opportunity to understand functioning of  Institutional Ethics Committee, Committee for Biomedical Research , Committee for Investigator Initiative Study Research , Scientific Committee. 


8. Opportunity to directly network with CRO Sponsor so that it is easy to get good placements.


9. Clinical Trial Start up activities including Informed Consent Process


10. Data Management- electronic data entry software

Placement Assistance : We will groom our students to face industry. We will work with them to make future successful Clinical Research Professionals.

•  Training -Soft Skills for a Clinical Research Professional


•  Training-Resume customization and Job interview preparation


•  Personal Assistance for Job Placement of student across Hospitals, Pharmaceutical companies, Contract Research Organizations (CRO), Site Management Organizations (SMO), Research Hospitals

ICH GCP - 1 Month Course : 

Good Clinical Practice (GCP) is an international ethical and scientific standard for conducting biomedical and behavioral research involving human participants. The objective of this guideline is to provide a unified standard across the European Union (EU), Japan, the United States, Canada, and Switzerland to facilitate the mutual acceptance of data from clinical trials by Regulatory Authorities.

Why to choose Bhaktivedanta Hospital and Research Institute for online Course : Apart from online teaching , candidates would also be offered one , on –site hands on training. 

Duration of course- 1 month, Saturday/Sunday Classes ( 3hrs Per Lecture )

Limited Batch Size- 10 students only 

Course /Training on NDCT Rule 2019 : The NDCT Rules are applicable to, and regulate, all new drugs, investigational new drugs for human use, clinical trials, bioequivalence studies, bioavailability studies and Ethics Committees.

Why to choose Bhaktivedanta Hospital and Research Institute for online Course : Apart from online teaching , candidates would also be offered one , on –site hands on training . 

Duration of course- 1 month, Saturday/Sunday Classes ( 3hrs Per Lecture )

Limited Batch Size. 

Course /Training on ICH GCP + NDCT Rule 2019 + ICMR

Why to choose Bhaktivedanta Hospital and Research Institute for online Course : Apart from online teaching , candidates would also be offered one , on –site hands on training .

Duration of course- 3 months, Saturday/Sunday Classes ( 3hrs Per Lecture )

Limited Batch Size.

Ethics Committee Members Training Program:

Why to choose Bhaktivedanta Hospital and Research Institute for online Course: We have three Ethics Committees operating in our Institute since last 7 years (which review Clinical Trials, Biomedical Research and Medical Post-graduation Academic Research Activities).  These committees are registered with Drug Controller General of India, accredited by NABH (Under Clinical Trial Program). Training module is created with case studies with rich experience of these Ethics Committee Members

Duration of course: -

v Physical Training Session of 8 Hours in Ethics Committee Members Organization (One Day Program)

v 1 month program , Every Saturday/Sunday Class ( 2-3 hrs. Per Lecture)

Limited Batch Size.